Package leaflet: Information for the patient

Finaster, 5 mg, film-coated tablets
Finasteridum

THIS MEDICINAL PRODUCT IS INTENDED FOR USE IN MEN ONLY
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

What Finaster is and what it is used for
Important information before taking Finaster
How to take Finaster
Possible side effects
How to store Finaster
Contents of the pack and other information

1. What Finaster is and what it is used for

Finasteride, the active substance in Finaster, is an inhibitor of 5-alpha-reductase, an enzyme that converts testosterone (a male sex hormone) into the more potent dihydrotestosterone (DHT). Finaster reduces the volume of the prostate gland.
Finaster is used in a condition called benign prostatic hyperplasia. The prostate gland, located near the urinary bladder, enlarges and causes difficulties in urination.
Finaster is indicated for the treatment of benign prostatic hyperplasia to:

relieve symptoms,
reduce the risk of acute urinary retention,
reduce the risk of needing surgical treatment, including transurethral resection of the prostate (TURP) and prostatectomy (surgical removal of the prostate gland).

2. Important information before using Finaster

What you should know before and during treatment with Finaster
If the patient's sexual partner is pregnant or suspected of being pregnant,
contact with the patient's semen, which may contain small amounts of the drug, should be avoided.

When not to use Finaster

if the patient is allergic (hypersensitive) to finasteride or any of the other ingredients
of this medicine (listed in section 6),
in pregnant women and women of childbearing age.

Finaster is not indicated for use in women.

Warnings and precautions

Before starting treatment with Finaster, discuss this with your doctor.
Inform your doctor about all current or past medical conditions and any allergies.
Benign prostatic hyperplasia (BPH) is a slowly progressive condition. In some patients, symptoms may improve shortly after starting therapy. However, treatment for at least 6 months may be necessary to achieve significant improvement. Regardless of whether symptoms improve, continued use of Finaster may reduce the risk of acute urinary retention and the need for surgical intervention. For monitoring treatment progress, the patient should remain under regular medical supervision.
Benign prostatic hyperplasia is not cancer and does not lead to cancer, but both conditions may coexist. Only a doctor can properly evaluate symptoms and their probable cause.
Treatment with Finaster may affect PSA (prostate-specific antigen) test results. Therefore, inform your doctor that you are taking Finaster before undergoing this test.
Finaster is indicated exclusively for use in men for the treatment of benign prostatic hyperplasia.

Mood changes and depression
Mood changes such as depressive mood and depression, and rarely suicidal thoughts, have been reported in patients taking Finaster. If any of these symptoms occur, seek immediate medical advice from your doctor.

Children
Finaster must not be used in children.

Finaster and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. Finaster usually does not affect the action of other medicines.

Pregnancy and breastfeeding

Pregnancy
Pregnant women and women of childbearing age must not take Finaster. They should also avoid handling crushed or broken Finaster tablets. If the active substance of the medicine enters the body (by oral administration or through skin contact) of a woman expecting a male child, it may cause developmental abnormalities of the fetal genital organs. In the event of exposure of a pregnant woman to the active substance of Finaster, a doctor should be informed. Finaster tablets are coated, which prevents direct contact with the active substance, provided the tablets are not damaged or crushed.
Your doctor can provide further information on this matter.

Breastfeeding
Finaster is not indicated for use in women.
It is unknown whether finasteride passes into human milk.

Driving and operating machinery
There are no data indicating that Finaster affects the ability to drive or operate machinery.

Finaster contains lactose
If the patient has previously been diagnosed with an intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

Finaster contains sodium
The medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, the medicine is considered "sodium-free".

3. How to use Finaster

This medicine should always be taken as directed by the physician. In case of doubt, consult your
doctor.
The recommended dose is one 5 mg tablet daily, regardless of meals. The medicine should be taken
orally.
Keep in mind that benign prostatic hyperplasia is a condition developing over many years before
symptoms become noticeable. Finaster may relieve symptoms and help control the progression of
the disease if taken regularly over a prolonged period.
Use of Finaster in patients with renal and/or hepatic impairment
Dosage adjustment is not required in patients with any degree of renal and/or hepatic impairment.
Use of Finaster in elderly patients
Dosage adjustment is not required in elderly patients.
Use of a higher than recommended dose of Finaster
If more tablets than recommended have been taken, contact your doctor immediately.
Missed dose of Finaster
Finaster should be taken as directed by the physician. However, if a dose is missed, do not take an additional tablet. Resume the prescribed dosing schedule the next day.
If you have any further questions concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.

Common (may occur in 1 to 10 out of 100 patients):

decreased libido,
impotence (inability to achieve erection),
reduced volume of ejaculate (amount of semen). This does not affect normal sexual function.

In some cases, these symptoms may resolve during treatment. However, if adverse symptoms persist, you should consult your doctor, who may decide to discontinue the use of Finaster.

Uncommon (may occur in 1 to 10 out of 1,000 patients):

breast enlargement and/or tenderness,
rash,
ejaculation disorders.

Frequency not known (frequency cannot be estimated from the available data):
Discontinue use of Finaster and contact your doctor immediately if any of the following symptoms occur (angioedema):
swelling of the face, tongue or throat, difficulty in swallowing, urticaria, and breathing difficulties.

allergic reactions: swelling of the lips, tongue, throat and face,
itching, urticaria,
palpitations,
changes in liver function, which may be observed in blood tests,
depression,
persistent decreased libido after discontinuation of treatment,
blood in semen,
testicular pain,
persistent inability to achieve erection after discontinuation of the drug,
persistent ejaculation disorders after discontinuation of the drug,
male infertility and/or poor semen quality (improvement in semen quality has been reported after discontinuation of the drug),
in rare cases, development of breast cancer,
anxiety,
suicidal thoughts.

Any changes observed in breast glandular tissue, such as lumps, pain, breast enlargement or nipple discharge, should be reported immediately to the treating physician, as they may indicate serious disorders such as breast cancer.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Finaster

Keep this medicine out of the sight and reach of children.
Store below 25 °C.
Do not use this medicine after the expiry date stated on the carton and blister pack. The expiry date refers to the last day of the stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Finaster contains

The active substance is finasteride. Each coated tablet contains 5 mg of finasteride.
The other ingredients are: tablet core: microcrystalline cellulose, lactose monohydrate, sodium croscarmellose, sodium lauryl sulfate, magnesium stearate, hydroxypropylcellulose; tablet coating: talc, polyvinyl alcohol (partially hydrolyzed), polyethylene glycol 3350, titanium dioxide (E171).

What Finaster looks like and contents of the pack
Finaster is a white, round, film-coated tablet with a smooth surface.
OPA/Aluminum/PVC/Aluminum blisters in a cardboard box.
The pack contains 30, 60, 90 or 120 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
LEK-AM Sp. z o.o. Pharmaceutical Company
Ostrzykowizna 14A
05-170 Zakroczym
tel.: +48 22 785 27 60